Technical writer - Artech LLC

6 months contract

Job Description: MSAT Technical Writer, Cell Therapy Vector Support ,Support, Manufacturing Science and Technology (MSAT)

The focus of the MSAT Technical Writer is to investigate and write root cause analyses for non-conformance events during the manufacturing of cell therapy vector.. The MSAT Tech Writer:

• Compiles and interprets manufacturing process data to identify possible failure modes
• Learns complex cell biology concepts & applies them to root cause investigations
• Works independently and with Process Engineer(s) to understand different failure modes
• Works with GMP Quality Systems to deliver completed Root Cause Analysis investigation reports

Education:

• BS in Bio/Chem Science/Engineering or related field
• Immunology education preferred

Required experience:

• 3+ years relevant experience in drug product biopharmaceutical or equivalent industry
• Deviation writing
• cGMP/cGDP
• Ability to prioritize multiple investigations in order to meet deadlines
• Strong scientific and technical acumen including technical writing skills

Preferred experience:

• Quality management system
• Complex problem-solving skills, including root cause investigation
• Cross-functional collaboration with engineering and quality partners
• Biologics or cell therapy manufacturing
• Trained in Kepner Tregoe Problem Solving

Duties and Responsibilities:

• Facilitates deviation closure through working with quality partners and site quality systems
• Analyzes and summarizes manufacturing data to support root cause investigations
• Analyzes and summarizes characterization data to write root cause investigations
• Utilizes root cause analysis tools such as fishbone, 6Ms, Five Whys, to identify root cause
• Writes technical and thorough investigation reports